The Scientist, Upstream Tech Transfer (PD/Tech Transfer) will report to the Associate Director of Tech Transfer and will have responsibilities supporting the upstream process development
technology transfer activities for viral vector pilot and GMP manufacturing campaigns. Candidates may have experience in cell culture, viral vector production, scale up, Tech Transfer, GxP
documentation, and technical report authoring and review. Experience in project management and Microsoft visio is a plus, but not required.
Responsibilities:
Work closely with process development scientist and/or client in process knowledge transfer to scale-up process for pilot scale
Support Process Fit to Plant evaluation
Author protocols to support pilot-scale manufacturing campaign
Provide planning and logistics support for pilot scale execution
Provide hands-on and technical support during execution of pilot-scale execution
Author knowledge transfer documentation for GMP manufacture (e.g., bill ofnmaterials, process flow diagrams, and sample plans)
Partner with manufacturing, engineering, and quality to establish process-specific batch records for GMP manufacture.
Collaborate with process development scientists and manufacturing to establish technology transfer plan and perform technical risk assessment for the product/process introduction to the GMP facility.
Provide technical support for process-related issues or investigations.
Provide scientific/engineering support for technology transfer and manufacturing of viral vectors
Requirements:
BS (4+ years experience) or MS (2+) in Chemical Engineering, Biology, or similar life sciences degree with experience in upstream technologies and demonstrated laboratory proficiency
Hands-on experience with common upstream pilot equipment and operations (i.e., Single
Use Bioreactors, adherent and suspension vector processes) and ability to train junior staff
Ability to follow procedures with attention to detail, and successfully execute experiments at the bench
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
Demonstrated ability to maintain detailed execution records and perform data analysis
Knowledge or experience with gene therapy manufacturing in the biotech industry is preferred
Strong communication skills (e.g., clear and concise) and a team player
Strong time and project management skills
Critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
Takes ownership of the assigned project, consulting with management and peers
Able to understand and interpret data/information and its practical application
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 30 pounds at times.
Standing/working in a lab setting for more than (4) hours when needed.